molindone
Trade name: moban
Approved
Jan 18, 1974
Molindone (Moban) is a therapeutic antipsychotic, used in the treatment of schizophrenia. The exact mechanism has not been established, however, based on electroencephalogram (EEG) studies, molindone is thought to act by occupying (antagonizing) dopamine (D2) receptor sites in the reticular limbic systems in the brain, thus decreasing dopamine activity. Decreased dopamine activity results in decreased physiological effects normally induced by excessive dopamine stimulation, such as those typically seen in manifestations of psychotic disorders. The side effect profile of molindone is similar to that of other typical antipsychotics. Unlike most antipsychotics, however, molindone use is associated with weight loss. — NCATS
Clinical trial activity
8 trials · 5 clinical orgs · 5 marketing orgs
Earliest trial started Feb 1, 2002 (NCT00053703)
Timeline
1970s
- Jan 18, 1974
Endo Pharmaceuticals — Earliest FDA Approval
- Jan 18, 1974
Endo Pharmaceuticals — NDA Secondary Org
- Jan 18, 1974
Strides Pharma Science — Marketing Organization
- Jan 18, 1974
Endo Pharmaceuticals — NDA Organization
- Jan 18, 1974
Strides Pharma Science — NDA Secondary Org
- Jan 18, 1974
Chartwell Pharmaceuticals — Marketing Organization
- Dec 28, 1979
DuPont — NDA Secondary Org
2000s
- Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
- Mar 20, 2015
Epic Pharma Llc — Marketing Organization
Indications
Approved for
Mechanism of action
- Serotonin 2a (5-HT2a) receptorANTAGONIST
HTR2A antagonist
- Dopamine D2 receptorANTAGONIST
DRD2 antagonist
Approval history
- approvedJan 18, 1974
Chemistry & pharmacology
SMILES
CCc1c(C)[nH]c2c1C(=O)C(CN1CCOCC1)CC2- Mol. weight
- 276.38 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL460 ↗
- WikipediaMolindone ↗
- NCATSRT3Y3QMF8N ↗
- ChEMBLCHEMBL1200419 ↗
Also known as
- en-1733a
- en-1733a
- moban
- moban
- moban
- moban
- molindona
- molindona
- molindone
- molindone
- molindone
- molindone
- molindone
- molindone
- molindone
- molindone
- molindone
- molindone
- molindone
- (+-)-molindone
- (+-)-molindone
- (+/-)-molindone
- molindone hcl
- molindone hcl
- molindone hcl
- molindone hydrochloride
- molindone hydrochloride
- molindone hydrochloride
- molindone hydrochloride
- molindone monohydrochloride
- molindonum
- molindonum
- spn-810
- spn-810
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02691182 | Phase 3 | Mar 1, 2016 | Supernus Pharmaceuticals |
| NCT02618408 | Phase 3 | Jan 1, 2016 | Supernus Pharmaceuticals |
| NCT02618434 | Phase 3 | Mar 1, 2015 | Supernus Pharmaceuticals |
| NCT02023606 | Phase 1 | Nov 1, 2013 | Quotient, Supernus Pharmaceuticals |
| NCT01416064 | Phase 2 | Sep 1, 2011 | Supernus Pharmaceuticals |
| NCT01364662 | Phase 2 | Jun 1, 2011 | Supernus Pharmaceuticals |
| NCT00626236 | Phase 2 | Sep 1, 2008 | Case Western Reserve University, Supernus Pharmaceuticals |
| NCT00053703 | Phase 4 | Feb 1, 2002 | National Institute of Mental Health (NIMH), University of North Carolina at Chapel Hill |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Supernus Pharmaceuticals | For profit | 7 | 7 | 3 | 2008 |
| Case Western Reserve University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| National Institute of Mental Health (NIMH) | Government | 1 | 0 | 1 | 2002 |
| Quotient | For profit | 1 | 0 | 1 | 2013 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 1 | 1 | 1 | 2002 |
Marketing (7)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Chartwell Pharmaceuticals | For profit | MKTG | Jan 18, 1974 |
| DuPont | For profit | NDA2 | Dec 28, 1979 |
| Endo Pharmaceuticals | For profit | NDA2 | Jan 18, 1974 |
| Endo Pharmaceuticals | For profit | NDA | Jan 18, 1974 |
| Epic Pharma Llc | For profit | MKTG | Mar 20, 2015 |
| Strides Pharma Science | For profit | MKTG | Jan 18, 1974 |
| Strides Pharma Science | For profit | NDA2 | Jan 18, 1974 |